The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include use of the vaccine as a two-dose primary series in adolescents 12-17 years old. The vaccine was authorized for primary immunization of adults in July 2022.

Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy, has been approved by the FDA for treatment of adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. It is the first adenoviral vector-based gene therapy to be approved in the US for this indication. The immune checkpoint inhibitor pembrolizumab (Keytruda) was approved for the same indication in 2021.

The possibility that use of mifepristone (Mifeprex, and generics) may be restricted has led to questions about alternatives for medication abortion.

Nogapendekin alfa inbakicept-pmln (Anktiva – ImmunityBio), a first-in-class interleukin-15 (IL15) receptor agonist, has been approved by the FDA for use with Bacillus Calmette-Guérin (BCG) for treatment of patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. Such patients generally undergo bladder tumor resection, followed by intravesical BCG treatment, but treatment failure and cancer recurrence are common. The adenoviral vector-based intravesical gene therapy nadofaragene firadenovec-vncg (Adstiladrin)...

The package inserts of the GLP-1 receptor agonists dulaglutide (Trulicity), exenatide (Byetta, Bydureon BCise), liraglutide (Saxenda, Victoza), and semaglutide (Ozempic, Rybelsus, Wegovy) and the dual glucosedependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Mounjaro, Zepbound) have been updated to include rare postmarketing reports of pulmonary aspiration associated with their use in patients undergoing elective surgery or other procedures requiring general anesthesia or deep sedation who had residual gastric contents despite preoperative...

Obecabtagene autoleucel (Aucatzyl – Autolus), a CD19-directed genetically modified autologous T cell immunotherapy, has been approved by the FDA for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. The CAR T-cell immunotherapy products tisagenlecleucel (Kymriah) and brexucabtagene auto-leucel (Tecartus) were approved earlier for the same indication.

According to the Centers for Disease Control (CDC), as of April 24 there have been 844 confirmed cases of measles in the US in 2025; 11% of cases have resulted in hospitalization and 3 patients have died. The majority of cases (96%) have been in unvaccinated persons or in those whose vaccination history was unknown

The FDA has approved osilodrostat (Isturisa – Recordati), a cortisol synthesis inhibitor, for oral treatment of adults with Cushing's disease when surgical resection of the pituitary adenoma is not an option or has not been curative. Osilodrostat is the first cortisol synthesis inhibitor to be approved in the US for this indication. Other oral steroidogenesis inhibitors such as ketoconazole and metyrapone have been used off-label for this indication for many years.

The FDA has approved the oral second-generation antipsychotic drug brexpiprazole (Rexulti – Otsuka/Lundbeck) for once-daily treatment of agitation associated with dementia due to Alzheimer's disease (AD). Brexpiprazole is the first drug to be approved in the US for this indication. It is also approved for treatment of schizophrenia and as an adjunct to antidepressants for treatment of major depressive disorder.

The FDA has approved sotagliflozin (Inpefa – Lexicon), an oral sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor, to reduce the risk of hospitalization for heart failure (HF), urgent HF visits, and cardiovascular death in adults with either HF (with any left ventricular ejection fraction [LVEF]) or type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular risk factors. Sotagliflozin is the first dual SGLT1/2 inhibitor to be approved in the US. Unlike SGLT2 inhibitors, it is not FDA-approved to improve glycemic control in adults with type 2 diabetes....